With its measurable impact on patient survival, there’s no denying that immunotherapy is already causing momentum in ways that cancer is treated. Drug researchers and developers are identifying new candidates in their growing pipelines and exploring combinations of immunotherapies, while regulatory agencies are providing expedited review and approval of these therapies for new indications at an unprecedented rate.
With checkpoint inhibitors from ipilimumab (Yervoy®) to nivolumab (Opdivo®) to pembrolizumab (Keytruda®) to the most recently approved atezolizumab (TecentriqTM), each breakthrough has provided new insights on how the immune system can be activated and manipulated to fight a variety of cancers. Continue reading →
The Development Landscape for Non-Alcoholic Steatohepatitis Q&A
Q&A with Claudia Filozof, MD, PhD, Senior Medical Director in the Phase II-IV Cardiovascular/Metabolic Group and Richard Williams, PhD, JD, Executive Strategist, Global Regulatory Affairs
Is this a good time to develop a NASH drug, and if so, why?
Claudia: Yes, it’s a very good time. There are multiple companies starting NASH development, and there is a huge unmet medical need with no treatment approved so far. Health authorities also have shown a lot of interest in supporting companies to speed up development. If you have the right compound, there are multiple advantages to starting a NASH program.
Richard: The cost to society will be enormous if we can’t treat this disease. I think most pharmaceutical companies, big and small, see this as a substantial unmet medical need. With this unmet medical need, regulatory agencies can grant conditional approval (accelerated approval in the US), where the drug is approved for marketing with the condition that the company later shows it has a clinical benefit based on clinical outcomes. Continue reading →
Among the regulatory pathways for small molecule drugs in the United States, the 505(b)(2) option occupies a middle ground. Intended for modifications of an existing treatment, it requires much more evidence than a generic but allows the sponsor to use data from a previous application. Companies can thus avoid unnecessarily repeating studies and shorten their development time.
At a recent Covance clinical seminar in Shanghai, attendees learned about the intricacies of 505(b)(2), the corresponding hybrid medicinal product pathway in the European Union and the differences from applications for biosimilars or generics. Developers in the Asia Pacific region are eager to better understand this topic because the Chinese pharmaceutical industry is developing rapidly with support from the government. “They view 505(b)(2) as a potentially faster way to market,” said Eric Lang, MD, Vice President and Global Head of Clinical Drug Development Leaders, Early Phase Development Solutions. To succeed, however, sponsors will need to consult with experts who can help them develop a regulatory strategy and consider market access issues as well. Continue reading →
As any drug developer knows, clinical trials generate a lot of raw and electronic data from multiple sources. Yet tracking progress and reviewing results from each separate database can be cumbersome in traditional environments. This “rear-view” mirror approach to monitoring doesn’t support preventative planning to mitigate future risks and can account for 20-30% of a trial’s costs.
Recognizing the opportunity increase efficiency and deliver information faster, Covance created Xcellerate® Monitoring, a platform that integrates clinical trial data to help sponsors proactively decrease the inherent risks associated with clinical trials.
At a recent clinical seminar in China, Dimitris Agrafiotis, PhD, Vice President, Chief Data Officer discussed how Xcellerate Monitoring tracks quality, patient safety and protocol compliance in clinical trials. Continue reading →
Drug development in China is progressing quickly, due in part to shifting regulations, increased innovation and growing opportunities for global partnerships. However, making the most of market opportunities requires not only a focus on the intended end results but also careful, early phase planning. At a recent clinical seminar in China, a panel of Covancemarket access experts shared their thoughts on how to increase a product’s commercial potential.
Incorporating a business case
“In China, we discussed the theme of ‘beginning with the end in mind,’” said Eric Lang, MD, Vice President and Global Head of Clinical Development Leaders, Early Phase Development Solutions. “We find that a lot of biopharmaceuticals are focused more on the science of their treatment and don’t realize that they also need a strong business case to develop a product,” he said. Continue reading →
Demonstrating the efficacy, safety and differential benefit of a new drug relies on collecting and analyzing enormous amounts of data generated in a clinical trial. Yet this process of extracting knowledge from data is often the source of many inefficiencies.
We recently spoke with Dimitris Agrafiotis, PhD, Vice President and Chief Data Officer at Covance to hear his thoughts on how informatics has affected drug development and will continue to transform the pharmaceutical industry.
Q: Why is informatics important in a global context?
More and more major businesses and industries are being run on software and delivered as online services―from movies to agriculture to national defense. Many of the winners of this new economy are Silicon Valley-style technology companies that are invading and overturning established industry structures. Continue reading →
Chinese biopharmaceuticals are expanding development beyond generics to focus on producing more personalized medicine, novel therapies, biomarkers and companion diagnostics. Steven Anderson, PhD, chief scientific officer at Covance, recently discussed his thoughts on biomarkers and precision medicine in China’s drug development and translational medicine landscape.
An emerging focus on biomarkers
“Efficacy of a drug therapy can vary widely and adverse effects can be common, but these parameters are not easily predicted,” explained Anderson. “That’s why biomarker-based, targeted treatments can guide therapy decision-making and better identify those individuals most likely to benefit.”
The Chinese pharmaceutical market continues to grow steadily, but drug developers in China face similar challenges as their global counterparts: Development times are increasing and success rates are declining. Xiaoning Guo, PhD, PMP, clinical development program director of Covance Asia Pacific, recently discussed potential strategies to improve investment returns and accelerate global development.
An evolving landscape
“Regulations in China have changed a lot with new policies and guidelines as the China Food and Drug Administration (CFDA) is strongly promoting innovation,” said Guo. “Domestic pharma companies in China can benefit from revised IND review timelines and approval processes to get their clinical trials in Phases I through III approved simultaneously.”
Each year, new medicines are launched globally but few are available to Chinese patients, in comparison to those in the US or EU. Drug developers are working to reduce this gap and expand the reach of new molecular entities (NMEs) so that they can improve healthcare to patients in need. Confronting this issue requires navigating the evolving regulatory environment in China and capitalizing on parallel development opportunities in the global market.
Bill Hanlon, PhD, vice president, head of Global Regulatory Affairs, shares some of the latest thoughts and strategies from his recent presentation at the Covance Clinical Seminar in China.
Last month while at Disruptive Innovations US, Soloman Babani, Global VP, Alliance Management at Covance caught up with Valerie Bowling from The Conference Forum to discuss the role of the CRO in creating disruptive innovations in pharma and clinical development. Check out the interview below to gain expert insight into the topics discussed at this unique event, which brought together senior leaders from top CROs to discuss this issue openly and honestly. Learn about what the future looks like, specifically related to profits and R&D spending, as well as what can be done to help reduce prices.